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Orbo Inc

⚠️ Moderate Risk

FEI: 1000446266 • Deal Island, MD • UNITED STATES

FEI

FEI Number

1000446266

📍

Location

Deal Island, MD

🇺🇸
🏢

Address

44, , Deal Island, MD, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
2/3/2006
Latest Refusal
2/3/2006
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
2/3/2006
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Orbo Inc's FDA import refusal history?

Orbo Inc (FEI: 1000446266) has 1 FDA import refusal record(s) in our database, spanning from 2/3/2006 to 2/3/2006.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Orbo Inc's FEI number is 1000446266.

What types of violations has Orbo Inc received?

Orbo Inc has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Orbo Inc come from?

All FDA import refusal data for Orbo Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.